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FDA 510(k)

Cosine-10TM Diagnostic Catheter

K-Number: K233397 · 2023-12-02

ApplicantMedtronic, Inc.
Decision Date2023-12-02
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cosine-10TM Diagnostic Catheter is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2023-12-02 under approval number K233397. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cosine-10TM Diagnostic Catheter?

Cosine-10TM Diagnostic Catheter is a medical device that received FDA 510(k) clearance on 2023-12-02. It is manufactured by Medtronic, Inc.. The 510(k) number is K233397.

When was Cosine-10TM Diagnostic Catheter approved by the FDA?

Cosine-10TM Diagnostic Catheter received FDA 510(k) clearance on 2023-12-02, under approval number K233397.

What company makes Cosine-10TM Diagnostic Catheter?

Cosine-10TM Diagnostic Catheter is manufactured by Medtronic, Inc..

What is the FDA product code for Cosine-10TM Diagnostic Catheter?

The FDA product code for Cosine-10TM Diagnostic Catheter is DRF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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